JP2006187658A - Bifurcated endoluminal prosthesis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sufficiently satisfactory bifurcated endoluminal prosthesis and its introduction system without requiring a by-pass operation when used as located close to a bifurcation of an artery or vein, or extended over the bifurcation. <P>SOLUTION: The system is for assembling the endoluminal prothesis inside the body cavity and displaying the direction of rotation of a segment of the endoluminal prosthesis when the segment of the endoluminal prosthesis is inserted into the body cavity. The system comprises a plurality of prosthesis segments engaged with each other inside the body cavity to form the endoluminal prosthesis and a radiopaque marker disposed in at least one prosthesis segment. A composite radiolucent image of the radiopaque marker varies according to the direction of rotation of the prosthesis segment inside the body cavity. The direction of rotation of the endoluminal prosthesis segment is displayed by the radiolucent image for optionally adjusting the direction of rotation. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a branch endoluminal prosthesis for use in a branched blood vessel (eg, an intrarenal portion of a mammalian aorta where the aorta branches into the common iliac artery). The present invention also provides stent connection means for connecting a stent (eg, a stent that forms part of an endoluminal prosthesis) with other stents, as well as for introducing the prosthesis into the vasculature. Devices and methods, and methods for treating vascular diseases.

  Stents are used to provide an endoluminal wall of a prosthesis (eg, in the case of stenosis, an unoccluded conduit for blood in the stenotic region). An endoluminal prosthesis comprises a stent having a woven prosthetic graft layer, for example, by removing the pressure on the weakened part of the artery to reduce the risk of occlusion or spontaneous rupture of the arterial wall Used to treat aneurysms. Typically, a stent or endoluminal prosthesis is a so-called “minimally invasive technique” (in this case, the stent is compressed radially inward and is required through the patient's skin by a catheter. Or by “cut down” techniques (in which case the blood vessels involved are exposed to the outside by simple surgical means) Transplanted to the site. When the stent is in place, the catheter is withdrawn and the stent is re-expanded or re-expanded within the vessel to a predetermined diameter.

  U.S. Patent No. 6,057,031 discloses a vascular stent having a length of corrugated or "zigzag" wire formed in a helix; the helix is generally cylindrical that forms the lumen inner wall of a prosthesis in use To define a wall. The corrugated form of wire allows for radial expansion and compression of the stent, and US Pat. No. 6,057,051 discloses that the stent can be delivered percutaneously and can be expanded in situ using a balloon catheter.

  U.S. Patent No. 6,057,031 discloses an expandable endoluminal graft composed of a tubular member formed from a plurality of intersecting elongated members that allows for radial expansion and compression of the stent.

U.S. Patent No. 6,057,031 discloses an endoluminal stent comprised of helically formed corrugated wires; the apexes of adjacent wire waves are fixed together so that each of the helical hoops is Supported by adjacent hoops to increase the overall strength of the stent and minimize the risk of plaque herniation; in some embodiments, the stent of US Pat. A tubular graft member to be formed is further provided.
U.S. Pat.No. 4,886,062 U.S. Pat.No. 4,733,665 European Patent Publication No. 0556850

  The prior art stents and prostheses described above are generally satisfactory for the treatment of aneurysms, stenosis and other vascular diseases at sites in the continuous, non-branched portion of an artery or vein.

  However, prior art stents and prostheses are used where the site where the stent or prosthesis is desired to be applied extends close to or spans the branch of the artery or vein (eg, from the mammalian aorta). It is not fully satisfactory for use (in branching to the common iliac artery). For example, in the case of an abdominal aortic aneurysm (“AAA”) in the intrarenal portion of the aorta where the aorta extends to one of the common iliac arteries, one of the prior art prostheses described above is connected to the common iliac beyond the bifurcation. When used on one of the arteries, the proximal end of the other common iliac artery is blocked; thus, one common iliac artery adjacent to the distal end of the prosthesis is replaced with the other blocked common iliac A bypass operation to connect to the artery is required. It will be apparent to those skilled in the art that it is desirable to avoid surgery as much as possible; therefore, the need for bypass surgery with the use of prior art prostheses in close proximity to arterial bifurcations is a significant disadvantage. Profit.

  Throughout this specification, the term “proximal” means “nearest to the heart” and the term “distal” means “most from the heart”. It means "furthest form the heart".

  According to one aspect of the present invention, a stent connection means is provided for connecting two endoluminal stents to each other and defining a continuous lumen through the two stents. The stent connecting means includes a first stent having a male engaging portion that can be compressed radially inward and a second stent having a female cooperating portion. The male engagement portion may be introduced into the female cooperating portion while being compressed radially inward and then expanded or expanded within the female cooperating portion. These arrangements are such that, in use, the mutual engagement of the male and female cooperating parts resists the axial separation of the two stents from each other.

  Typically, the first stent may have a proximal male engagement portion; the second stent may have a distal female cooperation portion. The male engagement portion may extend radially outward toward its extreme end and the female cooperating portion may taper radially inward toward its extreme end. In some embodiments, the male engagement portion may have a frustoconical wall extending outwardly toward its axially extreme end; the female engagement portion may have its axially extreme end It may have a frustoconical wall that tapers radially inward toward the part.

  Alternatively, the male engaging portion and the female cooperating portion can be substantially non-tapered; they can be substantially cylindrical.

  The male engagement portion of the first stent is in a radially compressed state and is elastically compressible radially inward so that it can self-re-expand and engage the female cooperating portion. possible. Typically, each of the first and second stents may be elastically compressible.

  Thus, in use, by using a catheter, the second stent can be delivered in a radially compressed state; when the second stent is located at the site of use, the catheter can be withdrawn, thereby causing the second stent to be Re-expand and engage the luminal surface of the vessel.

  The first stent is then inserted distally of the second stent such that the male engagement portion of the first stent is radially compressed and introduced into the female cooperating portion of the expanded second stent. Can be delivered percutaneously or by an "incision" technique; the catheter can then be withdrawn and the first stent such that the male engagement portion engages the female cooperating portion of the second stent. Re-extend.

  In some embodiments of the invention, the second stent may have two side-by-side distal female cooperating portions; thus, the second stent is for use proximate to a vessel bifurcation. Can be constructed.

  Each of the two side-by-side distal female cooperators can be adapted for connection with the first male stent, which in use extends across one of the bifurcated vessels across the bifurcation.

  In certain aspects of the invention, a branch endoluminal stent is provided for use proximate to a vascular branch; the branch endoluminal stent is disposed within a blood vessel proximate to the branch in use. A proximal portion adapted to be operated, a first distal stent portion adapted to extend to one of the branch vessels beyond the bifurcation point, and for flowing blood from the proximal portion to the other branch vessel And a second distal stent portion adapted to. The first distal stent portion can be integrally formed with the proximal portion.

  In some embodiments, the second distal stent portion is adapted to extend into other branch vessels such that the branch stent can be connected in situ with other stents in use. There may be provided a female cooperating portion adapted to engage with the male engaging portion. Thus, a branched intraluminal stent according to the present invention may constitute a second stent with a distal female cooperating portion disposed intermediate the proximal and distal extreme ends of the stent; The stent may constitute the first stent.

  Typically, the proximal end of the second stent may extend radially outward toward its extreme end to engage the intraluminal surface of the artery, thereby causing the axis of the second stent in use. Can resist movement in direction.

  Each of the first and second stents can comprise a corrugated wire formed in a tubular configuration. This wavy and tubular form can be obtained by winding a wire around a mandrel. Typically, each stent can be made from a shape memory nitinol (nickel-titanium alloy) wire that is wrapped around a mandrel and has a tubular form with a diameter slightly larger than the diameter of the vessel intended for use with the stent. Can be formed. The stent can be annealed at a high temperature and then allowed to cool in air so that it “remembers” the shape when the Nitinol wire is wrapped around the mandrel.

  The nitinol wire can be an “M” type nitinol wire that is martensite at temperatures below about 13 ° C. and austenite at temperatures above about 25 ° C .; thus, at body temperatures of 37 ° C., the “M” type wire Is recognized to be austenite. Typically, annealing can be performed at about 500 ° C. or higher for at least about 60 minutes; after cooling, the wire can be immersed in cold water and the wire attached to the mandrel in a malleable martensite form. Promotes removal. Typically, the cold water can have a temperature of less than about 10 ° C .; the wire can be immersed for about 5 minutes or more. An advantage of forming a stent according to the present invention with a nitinol wire is that the nitinol wire is “superelastic” in the austenitic form; thus, in use, the radially outward direction exerted by the stent on the vessel wall The force is substantially constant regardless of vessel diameter and expanded stent.

  In some embodiments, the wire may have a helical form as disclosed in US Pat. Alternatively, the wire may have a completely new form (i.e., a wire form that forms a plurality of hoops such that the plane that includes the periphery of each hoop is substantially perpendicular to the long axis of the stent). Each hoop may comprise a substantially complete turn, which is a wire having a wavy shape; if necessary, when each hoop is completed, the point of wire winding moves axially with respect to the winding axis The next hoop can then be formed. When the next hoop is completed, the wire winding point moves further in the axial direction with respect to the winding axis, and the next hoop is formed in sequence.

  It is recognized that the advantage of this new arrangement is that the plane of the hoop does not deviate from the long axis of the stent; the axial end of the stent is “square” to the long axis. Thus, when the stent is expanded or expanded in situ, there is substantially no twisting of the stent when the length of the stent is reduced. This is recognized to be a significant advantage. This is because, in the area of stenosis or aneurysm, it is desirable to minimize the movement of the stent within the blood vessel to reduce the possibility of trauma to the patient. Apart from the bifurcation embodiments taught herein, this shaped stent can be used in any application where stents have been commonly used so far.

  Typically, the stent of the present invention is also capable of apex of undulating wires in one hoop so that each hoop is supported by an adjacent hoop, regardless of the helical or steep modifications. ) To the adjacent vertices of adjacent hoops. The securing means may include, for example, a loop element of suture material that ties adjacent vertices together; the loop element may also include a loop formed of a thermoplastic material, such as polypropylene. Alternatively, the securing means may be a bead of thermoplastic material formed around adjacent vertices. Alternatively, the securing means can be a loop, ring or staple formed of a wire such as nitinol.

  The male and female cooperating portions of the first and second interengaging stents of the present invention can be formed separately from the remainder of the respective non-engaging portions of these stents and then engaged. The part and the non-engaging part can be fixed to each other by a fixing means.

  In one embodiment of the present invention, the proximal and distal stent portions of the bifurcated stent according to the present invention may be formed separately; the distal end of the proximal stent portion is wide of the first intermediate frustoconical stent portion. Can be secured to the proximal end; the narrow distal end of the first intermediate frustoconical stent portion can be secured to the proximal end of the distal stent portion. The female cooperating portion of the bifurcated stent may be constituted by a second frustoconical stent portion that is secured to the distal end of the proximal stent portion proximate to the first frustoconical portion.

  Alternatively, the first and second frustoconical portions can be omitted; the proximal and distal stent portions can be secured directly to each other.

  The female cooperating part may be constituted by a substantially cylindrical stent part fixed to the proximal stent part arranged side by side with the distal part.

  Each of the bifurcated first and second stents of the present invention may comprise a tubular graft layer formed from a biocompatible fabric proximate to the stent; the stent and graft layer are combined to create an endoluminal prosthesis. Configure the brace. Typically, the graft layer may be disposed on the outside of the stent; however, it will be appreciated that in some embodiments, the graft layer may be disposed on the inside of the stent. In some embodiments, the graft layer may be secured to the stent by a loop element such as a polypropylene loop. The biocompatible fabric can be a polyester fabric or a polytetrafluoroethylene fabric; typically, the fabric can be a woven fabric or a polyester fabric knitted into a warp. In some embodiments, the woven or warp knitted fabric may be formed into a seamless bifurcated shape as a sleeve for a bifurcated stent.

  In some embodiments, the male engagement portion of the first stent and the female cooperation portion of the second stent may remain uncovered. Alternatively, the fabric graft layer can extend to the proximal extreme end at the outer surface of the male engagement portion and can be folded over the distal extreme end of the female engagement portion to form an inner sleeve; The fabric outside the male engagement portion can abut the folded portion of the fabric inside the female cooperating portion to form a seal that substantially blocks blood.

  Accordingly, in one aspect, the present invention includes a branch endoluminal prosthesis comprising a branch stent according to the present invention and a tubular graft layer.

  A first stent having a male engagement portion may also include a tubular graft layer. If desired, the first prosthesis can be introduced in a radially compressed state so that the male engagement portion of the first prosthesis engages the intermediate female cooperating portion of the branch prosthesis; The first prosthesis is then re-expanded in situ so that the male engagement portion engages the female cooperating portion and the two prostheses resist axial separation in use.

  The bifurcation prosthesis can be adapted for use in the treatment of an abdominal aortic aneurysm in the intrarenal portion of the mammalian aorta proximate to the bifurcation of the common iliac artery. In use, a branch endoluminal prosthesis can be introduced with a catheter into the intrarenal portion of the artery so that the first distal stent portion extends into one of the branch iliac arteries; the catheter can then be withdrawn; The prosthesis can be re-expanded in situ.

  It will be appreciated by those skilled in the art that the prosthesis can be introduced into the site of use percutaneously or by “incision” techniques.

  Any of the stents according to the present invention may have wire barbs or hooks spaced on the periphery on its outer surface. The barbs or hooks are adapted to engage the endoluminal surface of the host aorta and resist axial movement or slipping of the stent in use. Typically, the barbs or hooks can be placed over the portion of the stent provided with the fabric graft layer so that the points of the arteries engaged with the barbs or hooks are covered with the fabric graft in use. It will be recognized by those skilled in the art that arterial wall trauma caused by hooks or barbs can cause emboli; therefore, providing a woven graft on barbs or hooks in use will cause such emboli to occur in the bloodstream. To help prevent this. Alternatively, the barbs can be sewn to the outer surface of the fabric.

  The male engagement portion of the first stent may be provided with hooks or barbs spaced around the periphery on its outer surface and engage the inner surface of the female cooperating means, thereby in use. The connection means for the axial separation of the stents from each other is enhanced.

  The present invention thus provides a connection means for connecting two stents axially to each other. It will be appreciated that this represents a significant step forward in the field. Because, for example, providing a branch endoluminal prosthesis for use in close proximity, ie, with a branch point of an artery, to connect one of the branch arteries to another branch artery without requiring bypass surgery Because it can.

  In particular, the present invention provides a branch endoluminal prosthesis that can be placed in the aorta proximate to the bifurcation point and extends to one of the branch arteries; the branch prosthesis is on other prostheses that extend to the other branch artery. Can be connected. The prosthesis can be delivered percutaneously or by an “incision” method and can be connected together in situ, such as, for example, an aneurysm or stenosis extending beyond a bifurcation in a blood vessel An effective treatment of any angiogenic disease that does not require bypass surgery is provided.

  In another aspect, the present invention provides an introducer for delivering a branch endoluminal stent or prosthesis to the vasculature at the vascular branch point where the blood vessel branches into two branch vessels. The stent or prosthesis has a proximal portion adapted for placement within a blood vessel and a distal portion adapted for placement at least partially in one of two branch vessels. . The introducer includes a tubular outer sheath, a proximal pusher at least partially disposed within the outer sheath, and a distal pusher at least partially disposed within the proximal pusher.

  The present invention further provides an introducer for delivering an endoluminal prosthesis having a proximal stent portion and a distal stent portion to a vasculature at a vascular branch point where the blood vessel branches into two branch vessels. To do. The introducer includes a tubular outer sheath, a proximal pusher having a proximal end disposed at least partially within the outer sheath and adapted to contact the proximal stent portion, and the proximal A distal pusher having a proximal end at least partially disposed within the distal pusher and adapted to contact the distal stent portion, and at least partially disposed within the distal pusher; A balloon catheter having an attached balloon.

  In another aspect, the present invention provides a branch vessel having a proximal portion and a first distal portion in a vasculature of a vascular branch point where a blood vessel branches into a first branch vessel and a second branch vessel. A method of delivering an intraluminal stent or prosthesis is provided. The method includes inserting a first introducer including a stent or prosthesis to a predetermined delivery position of the vasculature, where the first introducer includes an outer sheath, a proximal pusher, and a distal pusher. Pulling out the outer sheath of the first introducer while maintaining the proximal pusher in a fixed position until the proximal portion of the stent or prosthesis is placed in the blood vessel from the first introducer. An outer sheath and proximal while maintaining the distal pusher in a fixed position until the first distal portion of the stent or prosthesis is at least partially disposed within the first branch vessel from the first introducer Withdrawing the partial pusher; and withdrawing the first introducer from the vasculature.

  The present invention further provides a method of delivering an endoluminal prosthesis having a proximal stent portion and a distal stent portion to the vasculature at the angiographic bifurcation where the vessel branches into two branch vessels. . The method includes inserting an introducer including a prosthesis to a predetermined delivery position of the vasculature, wherein the introducer is attached to an outer sheath, a proximal stent portion pusher, and a distal stent portion pusher. A balloon catheter having a balloon; inflating the balloon to at least partially block blood flow in the blood vessel; proximally until the proximal stent portion of the prosthesis is placed in the blood vessel from the introducer Withdrawing the outer sheath of the introducer while maintaining the stent pusher in a fixed position; the fixed position of the distal stent pusher until the distal stent portion of the prosthesis is placed in the blood vessel from the introducer Withdrawing the outer sheath and the proximal stent portion pusher while maintaining the guide; and withdrawing the introducer from the vasculature That.

  In general, the present invention provides a method for treating an vascular disease at a bifurcation site where a blood vessel branches into a first branched blood vessel and a second branched blood vessel. The method of treatment includes placing a proximal portion of an endoluminal stent in a blood vessel; directing blood flow from the blood vessel along the first distal portion of the intraluminal stent to the first branch vessel; A first distal portion connecting to the proximal portion and extending to the first branch vessel; and directing blood flow from the blood vessel to the second branch vessel along the second distal portion of the endoluminal stent. Wherein the second distal portion connects to the proximal portion and extends to the second branch vessel. This method can be applied to aneurysms, obstructions or stenosis.

  The present invention, including the novel stent structure and its manufacturing method and their use, will now be described by way of example only and with reference to the accompanying drawings.

  The aspects, features and advantages of the present invention will be more readily understood by reading the following detailed description with reference to the accompanying drawings, in which:

  The present invention includes devices and methods for treating vascular diseases in any branch vessel. One example of such a branch vessel is the intrarenal portion of a mammalian aorta where the aorta branches into the common iliac artery. Examples of diseases that can be treated using the devices and methods of the present invention include aneurysms, stenosis, and obstruction.

  The bifurcated stent according to the present invention shown at 10 in FIG. 1A is composed of four different parts (ie, a proximal part 12, a first frustoconical part 14, a first distal part 16 and a second frustoconical part 18). A wire skeleton. The bifurcated stent 10 comprises a woven graft layer (FIGS. 6 and 7) for use as, for example, an endoluminal prosthesis in the intrarenal portion of a mammalian aorta proximate to a branch of the common iliac artery. . However, for use with different parts of the vascular system and different mammals, bifurcated stents (with or without a woven graft layer) can be constructed according to the present invention by varying the size of the stent accordingly. Is recognized.

  Each of the four portions of the bifurcated stent 10 is made in substantially the same manner by wrapping a shape memory Nitinol wire (typically a Nitinol M-type wire) around the mandrel 46.

  An example of the structure of the proximal portion 12 of the bifurcated stent 10 is shown in FIGS. 2A and 2B; a nitinol M-type wire having a diameter of typically 0.46 mm (0.018 inches) is wrapped around a mandrel 46 to form a plurality of hoops 20. Form. On the winding surface of the mandrel 46, a plurality of upright pins 47 are arranged in a zigzag pattern for each hoop 20, and as a result, in each of the hoops 20, the nitinol wire follows a wavy path and is arranged at the periphery. A plurality of vertices 22 are defined. Each of the hoops 20 is wound on the mandrel 46 such that the plane including the periphery of each hoop 20 is substantially perpendicular to the long axis of the mandrel.

  When one hoop 20 (eg, a hoop indicated by 20a) is formed, the nitinol wire winding point moves axially with respect to the axis of the mandrel 46 to form the next continuous hoop 20b. The stent shown in FIG. 2A is a stent formed on the mandrel 46 shown in FIG. 2B, after the stent has been axially cut and rotated 45 degrees to show the structure of the stent. It is.

  The proximal portion of the example bifurcated stent of FIG. 1A is formed on a mandrel having a diameter of about 24 mm and an axial length of about 55 mm. From FIGS. 1A, 2A and 2B, the proximal portion 12 comprises three hoops 20 of unit width at the proximal end 24 of the proximal portion 12, two intermediate hoops 25 of twice the unit width, and its distal Note that it is constituted by one hoop 20 of unit width at the leading edge 26. In the illustrated embodiment, the intermediate hoop 25 has a plurality of offsets 25a. The offset 25a is formed when the wire passes around the pin 47 on the mandrel 46. The offset 25a imparts stability to the stent. When the Nitinol wire is wound on the mandrel 46, the Nitinol wire is annealed at a high temperature and then allowed to cool.

  In this embodiment of the invention, the wire is annealed at a temperature of about 500 ° C. for 60 minutes and allowed to cool in air. The purpose of annealing is to allow the austenitic form of Nitinol wire to “remember” its shape when wound on the mandrel 46; therefore, the Nitinol wire “remembers” its wound shape. It is recognized that other temperatures and times for annealing are included within the scope of the present invention.

  After annealing and cooling, the wire is soaked in cold water below 10 ° C. for about 5 minutes; the wire is then removed from the mandrel and the adjacent apex 22 of the adjacent hoop 20 is anchored 99 (see FIG. 4A) ( In this example, they are fixed together by 0.003 inch polypropylene filaments). Each vertex 22 of each hoop 20 that has adjacent vertices of adjacent hoops 20 is tied to an adjacent vertex 22. However, it will be appreciated that in other embodiments of the invention, only some of the adjacent vertices 22 may be fixed in this manner.

  In addition to the polypropylene filaments, the securing means may include a loop element 99a of suture material that ties adjacent vertices together, as shown, for example, in FIG. 4B. The securing means may also include beads 99b formed from a thermoplastic material around adjacent vertices, as shown in FIG. 4C. Alternatively, the securing means can be a loop 99c, ring 99d, or staple 99e formed of a wire such as nitinol, as shown in FIGS. 4D, 4E and 4F, respectively.

  The first and second frustoconical portions 14, 18 of the illustrated skeleton are substantially the same as the proximal portion 12 by winding a nitinol wire over the mandrel, annealing the wire, and then removing the wire from the mandrel. Formed with. As shown in FIG. 1, the first and second truncated cone parts 14 and 18 are each constituted by three hoops 20 having a unit width. The mandrel is tapered such that the proximal end of each of the exemplary frustoconical portions 14, 18 is formed with a diameter of about 12 mm, and the respective distal end 32 is formed with a diameter of about 9 mm. The total length of each of the exemplary truncated cone portions 14, 18 is about 18 mm. The wire used for the truncated cone parts 14, 18 is a Nitinol M-type wire having a diameter of 0.28 mm (0.011 inch). The adjacent vertices 22 of each of the exemplary frustoconical sections 14, 18 are tied together using 0.03 inch polypropylene filaments as described above. The first and second frustoconical portions 14, 18 are connected to the distal end 26 of the proximal portion 12 of the stent 10 at the wider proximal end 30 of each of the frustoconical portions 14, 18 as shown in FIG. 1A. Are fixed side-by-side by fixing the apex 22 of the hoop 20 forming the proximal apex 22 of the hoop 20 at the distal end 26 of the proximal portion 12.

  An exemplary first distal portion 16 of the bifurcated stent 10 is typically axially spaced with a Nitinol M-type wire, typically 0.28 mm (0.011 inch) in diameter, wrapped around a mandrel, as shown in FIG. An exemplary first distal portion is about 66 mm long and has a uniform diameter of about 9 mm. The proximal end 34 of the distal portion 16 is in this embodiment using a 0.003 inch polypropylene filament to connect each apex 22 of the proximal end 34 of the first distal portion 16 to the distal end of the first frustoconical portion 14. By tying to the proximal apex of end 32, it is secured to the narrower distal end 32 of the first truncated cone 14.

  The proximal portion 12, the first and second frustoconical portions 14, 18, and the first distal portion 16 are each a biocompatible fabric (eg, a plain fabric made from 30 or 40 denier polyester). ) And a tubular graft layer (FIGS. 6 and 7). Tubular fabric layers can be attached to the proximal portion 12 and distal portion 16 of the stent 10, for example, by sewing around the apex 22 of the underlying skeleton with 0.003 inch polypropylene filaments. A stent covered with a fabric constitutes the form of an endoluminal prosthesis.

  The proximal portion 12 of the wire skeleton may comprise a plurality of hooks or barbs 43 spaced around the periphery. This hook or barb can protrude through the tubular fabric layer and, in use, can engage the endoluminal surface of the host aorta.

  The undulating shape due to each bend 20 of the wire skeleton of the stent 10 allows the prosthesis to be elastically radially compressed inward, so that the prosthesis is, for example, of the intra-renal portion of the aorta. It can be housed in a catheter (eg, a 16 or 18 French catheter) for transdermal or incisive delivery to an intraluminal site. Larger diameter catheters (eg, up to 20 French catheters) can be used to deliver the prosthesis using an “incision” procedure.

  Radiopaque markers can be attached to one or more ends of the stent and X-rays can be used to monitor the delivery of the stent. As shown in FIG. 4A, such radiopaque markers can typically include gold or platinum wire 17 crimped to the end of stent 16. Alternatively, as shown in the same FIG. 4A, the radiopaque marker can be a tube 17a placed around a length of wire on the stent. Typically, in a bifurcated stent, the marker is secured to the stent in alignment with the distal stent portion so that the distal stent portion can be aligned with one of the branch vessels in situ and inserted.

  The branch endoluminal prosthesis is positioned in the intrarenal portion of the aorta proximate the bifurcation of the common iliac artery such that the first distal portion 16 of the prosthesis extends to one of the common iliac arteries. The catheter is then withdrawn until the stent engages the intraluminal surface of the host aorta and the stent 10 is re-expanded to the shape wrapped around the mandrel (annealed shape). The barbs or hooks engage the luminal surface of the host aorta and resist axial movement or slipping of the prosthesis in use.

  When the bifurcation prosthesis is placed in the adapted position and re-expands, blood can flow from the aorta to the proximal portion 12 of the prosthesis, from which the blood passes through the frustoconical portion 14 and first distal portion 16 It will be appreciated that it can flow through one common iliac artery and also through the second frustoconical portion 18 into the other common iliac artery.

  If it is necessary to implant the prosthesis into the other common iliac artery, a second prosthesis comprising a second stent 40 as shown in FIG. 1B can be used. The second stent 40 includes a wire skeleton having a proximal frustoconical portion 42 and a distal portion 44. The distal portion 44 of the second stent 40 can also be covered with a tubular graft layer (FIGS. 5, 6, and 7) of a biocompatible fabric (eg, polyester or polytetrafluoroethylene).

  The proximal frustoconical portion 42 is configured in the same manner as the frustoconical portions 14, 18 of the bifurcated stent 10; the distal portion 44 is configured in the same manner as the distal portion 16 of the bifurcated stent 10. The distal end of the proximal truncated cone part 42 is fixed to the proximal end of the distal part 44 by fixing the adjacent apex with a polypropylene filament as described above.

  In use, the second prosthesis is compressed radially inward and housed in a catheter for percutaneous or “incision” delivery to the other common iliac artery. The proximal frustum portion 42 is guided by the second frustum portion 18 of the bifurcated stent 10 in a radially compressed state. The distal portion 14 is then engaged with the intraluminal surface of the other common iliac artery, and the outer surface of the proximal frustoconical portion 42 is engaged with the inner surface of the second frustoconical portion 18 of the bifurcated stent 10. The catheter is withdrawn and the second stent 40 is re-expanded to its memorized shape until it meets.

  For other stents described herein, the proximal frustoconical portion 42 may be formed with barbs or hooks 43 spaced about the periphery, as shown in FIG. 1B. This barb or hook engages the wire skeleton of the second frustoconical portion 18 of the bifurcated stent 10. When barbs 43 are present at the proximal portion 12, they engage the inner wall of the artery.

  The tapered shape of the second frustoconical portion 18 of the bifurcated stent 10 and the proximal frustoconical portion 42 of the second stent 40 is such that the prosthesis is locked together in the adapted position as described so that the prosthesis is axial in use. Resist separation. The barbs or hooks of the second stent 40 and / or the proximal frustoconical portion 42 help resist such axial separation.

  In another example of the present invention, as shown, the branch endoluminal prosthesis 50 includes a proximal portion 52 that tapers radially inwardly from its proximal end 54 to its distal end 56; A bifurcated stent comprising lateral and spaced first and second frustoconical sections 58, 60 secured to the distal end 56 of the proximal section 52; the proximal section 52 is biocompatible Covered with a tubular graft layer of fabric 62.

  In use, the prosthesis is delivered to the artery proximate to the arterial bifurcation percutaneously or by an “incision” method; blood can flow through the proximal frustocone 52 and the first and Each of the branched arteries can flow through the second truncated cones 58 and 60. If a prosthesis is required for one or both of the bifurcated arteries, another prosthesis comprising the above-described stent of the type of FIG. 1B covered with a fabric may be in close proximity to such another prosthesis. The distal end can be connected to the bifurcation prosthesis 50 by inserting it into one or both of the distal frustoconical portions 58, 60 of the prosthesis 50 and re-expanding to engage within it.

  Another modification of the present invention is shown in FIG. This figure shows a branch endoluminal prosthesis 70 having a proximal portion 72 secured to two side-by-side spaced apart frusto-conical intermediate portions 76, 78 at its distal end 74.

  One of the frusto-conical middle portions 76 is secured to the elongated distal portion 80 at its distal end. The proximal end 82 of the proximal portion 72 extends radially outward toward the proximal end 82 and, in use, engages the endoluminal surface of the host vessel. Except for this widened portion, the entire endoluminal prosthesis is covered with a woven graft layer, as shown in the figure; this graft layer is provided outside the wire skeleton, and the middle part of the other truncated cone Fold at the distal tip 84 of 78 to form an internal backing within the other frusto-conical middle section 78.

  In accordance with the present invention, the other frusto-conical middle portion 78 constitutes a female cooperating portion adapted to receive a male engaging portion of another prosthetic device designated at 86. The other prosthesis 86 includes a proximal frustoconical portion 88 that defines a male engagement portion and an elongated distal portion 90. The entirety of another prosthesis 86 is covered with a fabric graft layer, as shown. In use, the male engaging portion 88 of another prosthesis 86 enters and engages the female cooperating portion 78 of the bifurcated prosthesis 70 in situ in the manner previously described herein. The fabric layer of the male engagement portion 88 faces and contacts the folded portion of the fabric layer disposed inside the female cooperating portion 78, thereby forming a seal that substantially blocks blood.

  Yet another example of the present invention is shown in. Here, the branch endoluminal prosthesis 91 has a generally cylindrical proximal portion 92; this proximal portion 92 is connected at its distal end 93 to an elongated generally cylindrical distal portion 94. . The proximal portion 92 is also connected at its distal end 93 to a generally cylindrical intermediate portion 95 that is secured in a side-by-side spaced relationship to the elongated distal portion 94. The cylindrical intermediate portion 95 constitutes a female engaging portion adapted to receive the substantially cylindrical male engaging portion of a second elongated prosthesis (not shown). The male engaging portion has an external hook disposed at a distance from the peripheral portion, and engages with the female cooperating portion during use. As shown, the entire branch prosthesis 91 is covered with an outer fabric graft layer, except for the portion 96 of the proximal portion 92 that extends toward the proximal end 97.

  An example of a delivery system according to the present invention will be described with reference to FIGS. This system is used to deploy a bifurcated stent when the bifurcated stent 10 is covered with a fabric graft layer to form an endoluminal prosthesis. The introducer 100 includes an outer sheath 101. The outer sheath 101 is a cylindrical tube adapted to be inserted into the vasculature from the introduction point to the bifurcation site where the prosthesis is to be placed, either percutaneously or by an “incision” procedure. is there.

  A proximal pusher 102 is housed within the outer sheath 101. The proximal pusher 102 is a cylindrical tube having an outer diameter smaller than the inner diameter of the outer sheath 101. Proximal pusher 102 is preferably slidable along the length of outer sheath 101.

  Disposed within the proximal pusher 102 is a distal pusher 103. The distal pusher 103 is a cylindrical tube that is slidably provided in the proximal pusher 102. The distal pusher 103 is preferably adapted to slide along the entire length of the proximal pusher 102.

  A balloon catheter 104 is disposed in the distal portion 103. Balloon catheter 104 is adapted to slide within distal pusher 103. At the guiding end 105 of the balloon catheter 104 is a nose cone 106. A balloon 107 is attached to the balloon catheter 104 between the nose cone 106 and the proximal end 115 of the proximal pusher 102.

  As shown in FIG. 8G, which is a cross-sectional view in the AA direction of the balloon catheter 104 of FIG. 8F, the balloon catheter 104 has a guide wire conduit 104a. A guidewire conduit 104a extends along the entire length of the balloon catheter 104 for passing a guidewire (not shown) through the introducer 100. In the illustrated embodiment, the balloon catheter 104 also has an injection orifice 109 and an injection conduit 109a. An injection conduit 109a connects the injection orifice 109 to the injection site 108 at or near the distal end of the balloon catheter 104 as shown in FIG. 8E. Radiopaque liquid can be injected into the injection site 108, exits the injection orifice 109 through the injection conduit 109a, and enters the vasculature to monitor the placement of the prosthesis.

  Also, in the embodiment illustrated in FIGS. 8F and 8G, the balloon catheter 104 has an inflation orifice 110 disposed at the point where the balloon 107 is attached to the balloon catheter 104. Balloon inflation conduit 110a connects balloon inflation orifice 110 to balloon inflation site 111 (FIG. 8E). In the delivery of the prosthesis, the balloon 107 can be inflated or deflated from the balloon inflation site 111.

  In another embodiment shown in FIG. 9, seals 150, 151 can be disposed near the distal ends 160, 161 of the outer sheath 101 and proximal pusher 102. The seals 150, 151 can be formed of silicone tubes.

  FIG. 10A shows another embodiment of introducer 100. As shown in FIG. 10A, wings 112, 113 are provided at the distal end of introducer 100. Wing 112 is connected to proximal pusher 102 and wing 113 is connected to outer sheath 101. Wings 112 and 113 show the direction of rotation of the proximal pusher 102 and the outer sheath 101, respectively. This thus indicates the orientation of the proximal portion 12 within the outer sheath 101 and the orientation of the distal portion 16 within the proximal pusher 102. In the illustrated embodiment, the wings 112 and 113 are also provided with holes 112a and 113a.

  As shown in FIG. 10B, rods 128 or other securing devices are attached to wings 112 and 113 using bolts secured by wing nuts 129 or other securing means, for example, through holes 112a and 113a. obtain. The rod 128 prevents relative movement of the proximal pusher 102 and the outer sheath 101. A wing may also be provided on the distal pusher 103 and used to attach the distal pusher 103 to either the proximal pusher 102 or the outer sheath 101 using a fixation device as described above. obtain.

  As part of introducer 100, hemostatic valve 114 is also shown in FIG. 10A. The hemostatic valve 114 is connected to the distal pusher 103 and acts as a simple seal around the balloon catheter 104. Although it prevents fluid loss, the hemostatic valve 114 causes the balloon catheter 104 to slide within the distal pusher 103. Alternatively, a Touhy-Borst valve (not shown) may be used in place of the hemostatic valve 114. The Touhy-Borst valve is a device that can be manually tightened on the balloon catheter 104. By lightly tightening such a valve, the balloon catheter 104 can slide; by tightening such a valve, the balloon catheter 104 is fixed.

  In use, the prosthesis must first be loaded into the introducer 100. The outer sheath 101 is first removed from the introducer 100. A balloon catheter 104 is then passed along the distal portion 16 and the proximal portion 12 of the prosthesis. The prosthesis is then cooled to a temperature of about 10 ° C. or below 10 ° C. and compressed radially. For this purpose, the prosthesis can be immersed in cold water. Preferably, the prosthesis should be in water during the loading operation.

  The support stent 10 is compressed under the fabric cover of the prosthesis, resulting in excess fabric. This excess fabric can simply be clamped together and laid down on a prosthesis that has been folded and compressed axially.

  The radially prosthetic distal portion 16 of the prosthesis is then inserted into the proximal pusher 102. The outer sheath 101 is then pulled over the proximal portion 12 and the proximal pusher 102 of the prosthesis. A thread (not shown) can be attached to the proximal end of the proximal portion 12 of the prosthesis and passed through the outer sheath 101. This strand can then be used to pull the proximal portion 12 along the outer sheath 101. It is important that the prosthesis proximal portion 12 and distal portion 16 be properly aligned with the outer sheath 101 and the proximal pusher 102 during the loading process. In order to ensure proper alignment, landmarks can be placed outside the outer sheath 101 and the proximal pusher 102.

  Referring again to FIG. 8F, the outer surface of the proximal portion 12 contacts the outer sheath 101 and is radially restrained, and the outer surface of the distal portion 16 contacts the proximal pusher 102 and radially A prosthesis is inserted so that it is deterred. As shown in FIG. 8F, the end 115 of the proximal pusher 102 is axially engaged with the proximal portion 12 of the prosthesis.

  Balloon catheter 104 is positioned such that nose cone 106 passes just proximal end 117 of outer sheath 101. The introducer is now ready for insertion into the patient.

  Referring to FIG. 11, the introducer 100 passes through an introduction point (not shown) and enters the patient's skin (percutaneous operation) or the surgically exposed vasculature itself ("incision" operation). . The introducer 100 is inserted into the vasculature along the guide wire 170 from the introduction point to the desired delivery location at the vascular branch.

  As shown in FIG. 11, in the aorta, the introducer 100 is positioned such that the end 117 of the outer sheath 101 is approximately the same as the renal artery 180. The balloon catheter 104 is then extended while maintaining the outer sheath 101 in a fixed position. In this embodiment, the balloon catheter 104 is extended until the distal end 105 of the nose cone 106 is approximately 35 mm above the proximal tip 117 of the outer sheath 101. The outer sheath 101 is then withdrawn while maintaining the proximal pusher 102 in a fixed position until the proximal tip of the prosthesis is flush with the proximal tip 117 of the outer sheath 101. Note that the balloon catheter 104 does not move while the outer sheath 101 is withdrawn in this manner.

  The introducer 100 is then repositioned to place the prosthesis at the desired placement position. Proper placement can be facilitated by using radiopaque markers as described above. The balloon catheter 104 is then stretched so that the balloon 107 is above the renal artery 180. Then, as shown in FIG. 12, the balloon 107 is inflated to occlude the aorta.

  As shown in FIG. 13, while maintaining the proximal pusher 102 in a fixed position, the outer sheath 101 is withdrawn until the proximal tip of the prosthesis comes out of the outer sheath 101. Using the radiopaque marker 120 located at the proximal end of the prosthesis, the introducer is rotated until the proper alignment of the prosthesis is obtained. In the illustrated embodiment, the radiopaque marker 120 is a “V” shaped platinum wire knitted around the apex of the prosthesis. To ensure proper alignment, the stent should be rotated until only the outline of V is seen and appears as a straight line rather than "V".

  As shown in FIG. 14, with the proximal pusher 102 fixed, the proximal portion 12 is fully positioned from the end of the outer sheath 101, and the prosthetic frustoconical portion 18 is at the end 117. The outer sheath 101 is further pulled out until it just passes.

  The balloon 107 is then deflated and blood flows through the prosthesis proximal portion 12 and out of the frustoconical portion 18. The balloon 107 is drawn into the prosthesis until the distal end 118 of the nose cone 106 is just above the proximal end of the prosthesis. Then, as shown in FIG. 15, the balloon 107 is inflated, placing the prosthesis (which may have a barb (not shown) at its proximal end) against the wall of the aorta.

  The distal pusher 103 is then maintained in a fixed position while the outer sheath 101 is withdrawn. Once the outer sheath 101 is withdrawn to the point where the proximal end 117 of the outer sheath 101 is flush with the proximal end 115 of the proximal pusher 102, the distal pusher 103 remains in a fixed position, Both the outer sheath 101 and the proximal pusher 102 are withdrawn. As shown in FIG. 16, the outer sheath 101 and the proximal pusher 102 are withdrawn until the distal portion 16 of the prosthesis is placed past the proximal end 116 of the distal pusher 103. The balloon 107 is gradually deflated and blood flow is established through the proximal portion 12 of the prosthesis and out of the frustoconical portion 18. If desired, the balloon 107 can be used to model the distal portion 16 of the prosthesis by inflating the balloon at a location where the distal portion 16 needs to be expanded. Then, as shown in FIG. 17, the balloon 107 is deflated and the introducer 100 is withdrawn from the vasculature leaving the guide wire 170 in place.

  FIG. 21A shows an example of a second introducer device 300 used to position the second distal portion 44. The second introducer 300 in the illustrated embodiment includes a cylindrical outer sheath 301 and a female Luer lock assembly 310. The second introducer 300 also has a hemostasis valve 361 provided in its hub 362. The cartridge 311 shown in FIG. 21B is adapted to be attached to the second introducer 300. The cartridge 311 has a threaded male Luer lock assembly 312 provided at its proximal end. The cartridge 311 has an outer tube 313 that houses the inner tube 314.

  In use, a thin wall tube (not shown) is first passed through the distal portion 44. This tube serves as a guidewire guide that allows the guidewire to pass straight through the distal portion 44, as described below. The distal section 44 with the thin-walled tube is then cooled, radially compressed, and inside the cartridge 311 in the same manner as inserting the bifurcation prosthesis into the proximal pusher 102 and the outer sheath 101. Inserted into tube 314. When the distal portion 44 is loaded into the inner tube 314 of the cartridge 311, a thin wall tube that serves as a guide wire guide extends out from both ends of the cartridge 311.

  Next, as shown in FIG. 18, a guide wire 171 is inserted through the proximal stent portion 12 to the bifurcation site of the vasculature. Next, a dialator 359 (FIG. 21C) having an outer diameter slightly smaller than the inner diameter of the second introducer 300 so that the tapered end 360 extends from the end 320 of the second introducer 300. The second introduction instrument 300 is inserted. The end 360 of the dialer 359 has a hole in it (slightly larger than the guide wire 171 and gradually tapers outward from the hole to the outer diameter of the dialer 359).

  Next, the second introducer 300 is inserted into the vasculature along the guide wire 171 by passing the guide wire 171 through the dialer 359. A dialator 359 having a tapered end 360 provides a smooth transition in the blood vessel from the diameter of the guide wire 171 to the diameter of the second introducer 300. As shown in FIG. 19, the second introducer 300 is moved so that the outer sheath 301 is inside the frustoconical portion 18 of the proximal portion 12 (in this embodiment, at least 20 mm inside). The dialator 359 is then removed from the second introducer 300 and the vasculature and retracted.

  The cartridge 311 is then passed over the guide wire 171 by passing the guide wire along a thin wall guide wire guide within the distal portion 44 within the cartridge 311. The guide wire guide is then removed and retracted.

  The cartridge 311 is then firmly engaged with the introducer 300 by engaging the male Luer lock assembly 310 with the female Luer lock assembly 312. Such a tight engagement prevents relative movement of the cartridge 311 and the introducer 300. By preventing relative movement, stability and reliability is achieved for the insertion process that has not been achieved previously.

  The pusher 315 is then inserted into the inner tube 314 of the cartridge 311 such that the proximal end 317 of the pusher 315 is in axial contact with the distal end of the distal portion 44 within the inner tube 314. Pusher 315 pushes distal portion 44 through cartridge 311 into outer sheath 301 of introducer 300. The distal portion 44 is pushed through the outer sheath 301 (which remains in a fixed position) until the distal portion 44 reaches the proximal end 320 of the outer sheath 301 (see FIG. 19). Again, a radiopaque marker 120 can be used to properly align the distal portion 44 with the proximal portion 12.

  The pusher 302 is held firmly in place and the outer sheath 301 is pulled out about 2 cm. In this way, the truncated cone part 42 of the distal part 44 is arranged inside the truncated cone part 18 as shown in FIG. The outer surface of the truncated cone portion 42 engages the inner surface of the truncated cone portion 18 so that the distal portion 44 connects to the proximal portion 12 and resists axial separation.

  Then, as shown in FIG. 20, the outer sheath 301 can be withdrawn so that the distal portion 44 is fully positioned while maintaining the pusher 302 in a fixed position. A balloon catheter 104 can be inserted through the outer sheath 301 to model the distal portion 44, if desired. The introducer 301 and guide wires 170, 171 are then retracted from the vasculature and the introduction point is closed.

  The delivery devices and methods described above are particularly useful for the treatment of abdominal aortic aneurysms using the bifurcation prosthesis according to the present invention. Other diseases and other embodiments of prostheses and delivery methods are described below.

  In the case of an abdominal aortic aneurysm adjacent to the aorta and not wide enough to affect the iliac artery, a straight (ie, unbranched) stent may be used. Preferably, for such applications, the linear stent comprises a composite of at least two stent segments aligned in the axial direction. Two embodiments of such a linear stent are described herein, each including requirements for an axially aligned stent, each requirement including: one perpendicular to a common axis There are these adjacent hoops, and each hoop is formed of a wavy or zigzag shaped wire and some or all of the adjacent vertices in the adjacent hoops are secured together.

  Initially, referring to FIG. 22, the linear stent 400 has a proximal stent portion (or segment) 401, a distal stent portion 402, and an intermediate portion 403.

  Proximal portion 401 is a ring of a number of hoops 20 spaced axially as described above with respect to the formation of stent 10. In the illustrated embodiment, two hoops 20 are used, each hoop 20 having a unit width.

  The distal portion 402 is also a ring made of the hoop 20 arranged in the axial direction as described above. In the illustrated embodiment, the distal ring 402 has two unit width hoops 20.

  The middle portion 403 of the linear stent 400 is formed from a biocompatible fabric (eg, a flat fabric made from 30 or 40 denier polyester). In this embodiment, the intermediate fabric section 403 does not cover the stent. The fabric portion 403 is attached to the proximal and distal stent portions at the proximal and distal ends, for example, by stitching around the apex 22 of the stent portion with, for example, 0.003 inch polypropylene filaments. Other than such a connection at the axial end, the intermediate fabric section 403 is not supported at all by the stent.

  A second embodiment of a linear stent that can be used in accordance with the present invention is shown in FIG. The linear stent 450 includes a stent portion 451 configured with a wire loop as described above with respect to the stent portions 401 and 402. The stent portion 451 is partially covered with a fabric 452. In this embodiment, the fabric portion 451 covers the stent 450 and is supported by the stent. On the other hand, for the stent 400, the fabric portion 403 is not supported by the stent.

  As shown in FIG. 24A, to treat an abdominal aortic aneurysm that does not extend to the wall of the iliac artery, a linear stent 400 (or 450) is deployed as shown in FIG. Proximal stent portion 401 engages the inner wall of the aorta above the aneurysm. The distal stent portion 402 engages the inner wall of the aorta below the aneurysm. The intermediate fabric portion 403 extends across the aneurysm and provides a strong and stable lumen for blood flow through the blood vessel.

  FIG. 28 shows a delivery device used to implant a linear stent 400 in the vasculature. This device is very similar to the device of the delivery system used with the bifurcated stent or prosthesis described above. Accordingly, like reference numerals refer to the same components.

  In the introducer 410 shown in FIG. 28, the proximal pusher 102 engages the proximal stent portion 401. Distal pusher 103 engages distal stent portion 402.

  In use, as described above with respect to the bifurcated stent or prosthesis, the linear stent 400 initially cools it to a temperature below 10 ° C., compresses it radially, and inserts it into the outer sheath 101. Is loaded into the introduction device. The remaining portion of introducer 410 is also assembled as described with respect to introducer 100.

  As shown in FIG. 24A, the introducer 410 passes through an introduction point (not shown) along the guidewire 411. This insertion can be accomplished using percutaneous or incision techniques. The introducer 410 is then inserted to the desired delivery position.

  As described above for the bifurcated stent and as shown in FIG. 24A, an introducer 410 is placed in the aorta and the balloon 107 is inflated above the renal artery.

  As shown in FIG. 24B, while maintaining the proximal pusher 102 in a fixed position, the outer sheath 101 is withdrawn until the proximal portion 401 of the stent 400 comes out of the outer sheath 101. Using a radiopaque marker 420 disposed on the proximal end of the proximal portion 401, the stent 400 is optimally aligned within the aorta. As shown in FIG. 25, the outer sheath 101 is further pulled out until the proximal portion 401 comes out of the outer sheath. The outer sheath 101 is then further pulled out until it is flush with the proximal pusher 102. The outer sheath 101 and the proximal pusher 102 are then pulled together while maintaining the distal pusher 103 in a fixed position. Accordingly, as shown in FIG. 26, the distal portion 402 is disposed from the end of the outer sheath 101.

  Next, as shown in FIG. 27, the balloon 107 is deflated and retracted into the proximal portion 401, where the balloon 107 is reinflated and the stent 400 is installed. Subsequently, the balloon 107 is pulled out together with the introduction device 410 in the same manner as described above, and the introduction point is closed.

  FIG. 29 shows an apparatus used to deploy the linear stent 450 of the present invention shown in FIG. This device is very similar to the device of the delivery system used with the bifurcated stent or prosthesis described above. Accordingly, like reference numerals refer to the same components.

  In this embodiment, the proximal pusher 102 is secured to the distal pusher 103 so that the ends 115 and 116 are coplanar. These coplanar ends are adapted to engage the stent 450 within the outer sheath 101.

  In use, as described above with respect to the bifurcated stent or prosthesis, the linear stent 450 initially cools it to a temperature below 10 ° C., compresses it radially, and inserts it into the outer sheath 101. By doing so, the introduction device 490 is loaded. The remaining portion of introducer 490 is also assembled as described with respect to introducer 100.

  As shown in FIG. 30, introducer 490 passes through an introduction point (not shown) along guidewire 411. This insertion can be accomplished using percutaneous or incision techniques. The introducer 490 is then inserted to the desired delivery position.

  In the same way as described above for the bifurcated stent and as shown in FIG. 31, an introducer 490 is placed in the aorta and the balloon 107 is inflated above the renal artery.

  As shown in FIG. 32, while the secured proximal pusher 102 and distal pusher 103 are maintained in a fixed position, the proximal portion 451 of the stent 450 emerges from the outer sheath 101 until the outer sheath 101 101 is drawn. Using a radiopaque marker 420 located at the proximal end of the proximal portion 451, the stent 450 is optimally aligned within the aorta. The outer sheath 101 is then fully withdrawn until the stent 450 is placed in the aorta, as shown in FIG.

  Next, as shown in FIG. 34, the balloon 107 is deflated and retracted into the proximal portion 451 where the balloon 107 is reinflated and the stent 450 is installed. The balloon 107 is then withdrawn with the introducer 490 in the same manner as described above and the introduction point is closed.

  An obstruction, a vascular disease, is the blockage of an artery with a soft thrombus buildup or clot. There are two types of obstruction that can occur at the aortic-iliac bifurcation. The first is intrarenal obstruction. In this case, the aortic block extends from just below the renal artery to the iliac artery. The second type is obstruction limited to the area of the bifurcation point itself.

  To treat intrarenal obstruction, a conduit through the thrombus is first formed by methods known in the art. The bifurcated endoluminal prosthesis of the present invention is then implanted at the bifurcation site to provide an uncapped lumen extending from the aorta to each iliac artery. Thus, blood can flow freely from the aorta to the iliac artery.

  The branch lumen prosthesis of the present invention used to treat obstruction must be covered with a fabric. This is necessary to prevent occlusion from thrombus remaining on the re-conduited arterial wall.

  Blockage obstruction is treated by arterial reconduit formation as described above. The branch endoluminal prosthesis of the present invention can be implanted at a bifurcation point. However, the proximal portion of the prosthesis can be shorter than described above because the obstruction is limited to the area of the bifurcation itself.

  A delivery system for delivering a branch endoluminal prosthesis for treating an abdominal aortic aneurysm comprising the introducer 100 described above for implanting a branch endoluminal prosthesis for treating both types of obstruction Is used. A delivery method similar to that described above for implanting a branch endoluminal prosthesis for treating an abdominal aortic aneurysm is used to implant a device for treating an obstruction.

  Using the method and apparatus of the present invention to treat obstruction provides an unoccluded lumen through which blood flows freely from the aorta to the iliac artery.

  Stenosis, a vascular disease, is a narrowing of the artery due to the accumulation of hard calcified plaques. This is usually caused by cholesterol accumulation. In order to treat such vascular diseases, angioplasty is performed on the plaques by methods well known in the art. The branch endoluminal stent of the present invention is then implanted at the bifurcation site. This stent is similar to that described above for the treatment of abdominal aortic aneurysms. However, it is not necessary to cover the stent with a fabric in order to treat stenosis. Therefore, there is no need to produce a prosthesis. Because stenosis at the bifurcation site is rare, it is not necessary to isolate the blood flow in the lumen from the arterial wall.

  The delivery system used to implant the branch endoluminal stent used to treat stenosis is similar to the system shown in FIG. 8 except that the balloon 107 is not required. Since there is no fabric around the stent that is affected by blood flow in the arteries and causes migration of the bifurcated stent, there is no need to block blood flow with a balloon. Otherwise, the delivery system for implanting a bifurcated stent to treat stenosis is similar to the delivery system for implanting a bifurcated endoluminal prosthesis to treat an abdominal aortic aneurysm.

  Similarly, a method for delivering a bifurcated intraluminal stent to treat stenosis, except for the step comprising inflating the balloon 107 to block blood flow, provides a bifurcation for treating an abdominal aortic aneurysm. Similar to the method described above for delivering an endoluminal prosthesis.

1 is a front view of a branch endoluminal stent according to the present invention that forms part of an endoluminal prosthesis. FIG. 1B is a front view of another stent adapted to connect to the bifurcated stent of FIG. 1A. FIG. FIG. 1B is a side view of a portion of the bifurcated stent of FIG. 1A expanded to show its structure. FIG. 2B is a side view of an example of a mandrel used to form a portion of the bifurcated stent shown in FIG. 2A. FIG. 1B is a side view of another portion of the bifurcated stent of FIG. 1A expanded to show its structure. FIG. 2 is a side view of yet another portion of the bifurcated stent of FIG. 1A expanded to show its structure. FIG. 4B is a partially exploded view of the exemplary stent of FIG. 4A illustrating an example of a means for fixing adjacent vertices according to the present invention. FIG. 4B is a partially exploded view of the exemplary stent of FIG. 4A illustrating an example of a means for fixing adjacent vertices according to the present invention. FIG. 4B is a partially exploded view of the exemplary stent of FIG. 4A illustrating an example of a means for fixing adjacent vertices according to the present invention. FIG. 4B is a partially exploded view of the exemplary stent of FIG. 4A illustrating an example of a means for fixing adjacent vertices according to the present invention. FIG. 4B is a partially exploded view of the exemplary stent of FIG. 4A illustrating an example of a means for fixing adjacent vertices according to the present invention. 1 is a schematic perspective view of a branch lumen prosthesis according to the present invention. FIG. FIG. 6 is a schematic perspective view of another branch endoluminal prosthesis according to the present invention. FIG. 6 is a schematic perspective view of yet another branch endoluminal prosthesis according to the present invention. It is sectional drawing which shows an example of the assembled introduction tool by this invention. FIG. 8B is a side view of a component part of the introduction device of FIG. 8A. FIG. 8B is a side view of a component part of the introduction device of FIG. 8A. FIG. 8B is a side view of a component part of the introduction device of FIG. 8A. FIG. 8B is a side view of a component part of the introduction device of FIG. 8A. FIG. 8B is a side view of a component part of the introduction device of FIG. 8A. FIG. 9 is a cross-sectional view of a part of the introduction device of FIG. 8F cut along the line AA. FIG. 6 is a partial side cross-sectional view showing another embodiment of the introducer according to the present invention. FIG. 6 is a side view showing still another embodiment of the introduction device according to the present invention. FIG. 6 is a side view showing still another embodiment of the introduction device according to the present invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. FIG. 6 is a cross-sectional view showing another insertion device according to the present invention. FIG. 6 is a cross-sectional view showing another insertion device according to the present invention. FIG. 6 is a cross-sectional view showing another insertion device according to the present invention. FIG. 6 is a side view of another stent according to the present invention. FIG. 6 is a side view of another stent according to the present invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. FIG. 5 is a cross-sectional side view of another delivery device according to the present invention. FIG. 5 is a cross-sectional side view of another delivery device according to the present invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention. It is sectional drawing of the branch of the abdominal aorta which shows the introduction process in the case of introduce | transducing an example of the prosthesis by this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Bifurcated stent 12 Proximal part 14 1st frustoconical part 16 1st distal part 17 Platinum wire 17a Tube 18 2nd frustoconical part 20 Hoop 22 Apex 25 Middle hoop 26 Distal end 30 Proximal end 32 Distal end 40 Second stent 42 Proximal frustum portion 43 Hook 44 Distal portion 50 Branch lumen prosthesis 52 Proximal portion 54 Proximal end 56 Distal end 58 First frustum portion 60 Second frustum portion 70 Branch lumen Endoprosthesis 72 Proximal part 74 Distal end 78 Female cooperating part 80 Distal part 82 Proximal end 86 Prosthesis 88 Proximal frustum part (male engaging part)
DESCRIPTION OF SYMBOLS 90 Distal part 91 Branch endoluminal prosthesis 92 Proximal part 94 Distal part 95 Middle part 97 Proximal end 100 Introduction instrument 101 External sheath 101
102 Proximal pusher 103 Distal pusher 104 Balloon catheter 107 Balloon 109a Infusion conduit 114 Hemostatic valve 120 Radiopaque marker 170,171 Guide wire 300 Second introducer instrument 301 External sheath 302 Pusher 310 Female Luer lock assembly 311 Cartridge 312 Male Luer Lock Assembly 313 Outer Tube 314 Inner Tube 315 Pusher 359 Dialer 400 Linear Stent
401 Proximal Stent 402 Distal Stent 403 Intermediate 410 Introducing Instrument 411 Guide Wire 420 Radiopaque Marker 450 Stent 451 Proximal 490 Introducing Instrument

Claims (8)

A branch prosthesis adapted to deploy at a bifurcation branching into two branch vessels,
A bifurcated proximal portion adapted to be placed in the vessel via one of the branch vessels;
A distal portion adapted to be connected with another prosthesis deployed in the lumen via the other of the branch vessels;
A branch prosthesis comprising:   2. The branch prosthesis of claim 1 having a second distal portion adapted to extend from the distal distal end into the branch vessel as the branch prosthesis is deployed, via the branch vessel. And the branch prosthesis is deployed.   The branch prosthesis of claim 1, wherein the proximal portion, the distal portion, and the separation prosthesis each comprise a combination of a stent and a graft.   4. The branch prosthesis of claim 3, wherein the distal portion and the graft of the separation prosthesis are adapted to form a continuous lumen extending from the branched proximal portion to the other branch vessel. Branch prosthesis characterized by A system for assembling an endoluminal prosthesis in a body cavity and indicating the direction of rotation of the segment during insertion of the segment of the endoluminal prosthesis into the body cavity,
A plurality of prosthetic segments configured to engage with each other within the body cavity to form the endoluminal prosthesis;
Radiopaque markers disposed on at least one of the prosthetic segments, such that a combined radiographic image of the radiopaque markers changes depending on the direction of rotation of the prosthetic segment in the body cavity. A radiopaque marker made,
The direction of rotation of the prosthetic segment within the lumen is displayed by the radiographic image to optionally adjust the direction of rotation;
A system characterized by that.   6. The system according to claim 5, wherein a plurality of the radiopaque markers are provided, and each of the radiopaque markers is a “V” -shaped leg, so that the “V” is defined by the radiopaque markers. A system characterized in that a shape is formed.   6. The system of claim 5, wherein the radiopaque marker is located proximate to an end of the prosthetic segment. A system for assembling an endoluminal prosthesis in a body vessel,
A plurality of prosthetic segments configured to be inserted into the body vessel, the plurality of prosthetic segments configured to be engageable with each other to form the endoluminal prosthesis within the vessel; Prepared,
At least a portion of the prosthetic segment is provided with a radiopaque marker that facilitates accurate alignment of the prosthetic segments with each other during insertion of the prosthetic segment. A system characterized by that.

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